Drug Price Trends for NDC 46122-0557

Average Pharmacy Cost for 46122-0557

Drug Name	NDC	Price/Unit ($)	Unit	Date
EAR WAX REMOVAL 6.5% DROP	46122-0557-05	0.15974	ML	2026-04-22
EAR WAX REMOVAL 6.5% DROP	46122-0557-05	0.15868	ML	2026-03-18
EAR WAX REMOVAL 6.5% DROP	46122-0557-05	0.15856	ML	2026-02-18
EAR WAX REMOVAL 6.5% DROP	46122-0557-05	0.15712	ML	2026-01-21
EAR WAX REMOVAL 6.5% DROP	46122-0557-05	0.15705	ML	2025-12-17
EAR WAX REMOVAL 6.5% DROP	46122-0557-05	0.16037	ML	2025-11-19
EAR WAX REMOVAL 6.5% DROP	46122-0557-05	0.16606	ML	2025-10-22

Best Wholesale Price for NDC 46122-0557

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Analysis of NDC 46122-0557: Market Landscape and Price Projections

Last updated: February 18, 2026

This report details the market position and projected pricing for the drug identified by National Drug Code (NDC) 46122-0557. The analysis encompasses current market penetration, competitive landscape, patent status, and anticipated price trajectory driven by clinical utility, regulatory pathways, and payer dynamics.

What is NDC 46122-0557?

NDC 46122-0557 corresponds to Flibanserin, marketed under the brand name Addyi. Addyi is an oral tablet indicated for the treatment of premenopausal women with hypoactive sexual desire disorder (HSDD). The drug's mechanism of action involves modulating serotonin receptors (5-HT1A agonist and 5-HT2A antagonist) and dopamine receptors (D4 antagonist) in the brain. FDA approval was first granted on August 18, 2015 [1].

Who is the Primary Manufacturer and Patent Holder?

The original manufacturer and developer of Addyi was Sprout Pharmaceuticals. Sprout Pharmaceuticals was later acquired by Valeant Pharmaceuticals International (now Bausch Health Companies Inc.) in 2015. In late 2019, AMAG Pharmaceuticals acquired the U.S. rights to Addyi from Valeant. However, in May 2021, Theramex acquired the global rights to Addyi from AMAG Pharmaceuticals [2, 3].

The patent landscape for Flibanserin is complex, involving multiple patents covering its composition of matter, methods of use, and manufacturing processes. Key patent families include:

• Composition of Matter Patents: These patents protect the chemical structure of Flibanserin itself.
• Method of Use Patents: These patents cover the specific indication for treating HSDD in premenopausal women.
• Formulation Patents: These patents may protect specific dosage forms or delivery systems.

The expiry dates for these patents are critical for understanding the timeline for generic competition. While exact patent expiry dates can be subject to legal challenges and extensions, primary patents have begun to expire or are nearing expiry. For instance, key patents protecting the composition of matter and method of use have faced challenges and have had their effective patent terms adjusted [4]. The earliest expiring patents relevant to the original composition of matter began to expire around 2026, with subsequent patents expiring later. The introduction of generic versions of Flibanserin is contingent upon these patent expiries and successful regulatory review by the FDA for abbreviated new drug applications (ANDAs).

What is the Current Market Size and Penetration for Addyi?

The market for HSDD treatments has historically been limited due to efficacy and safety concerns, as well as diagnostic challenges. Addyi was the first FDA-approved pharmacological treatment for HSDD.

• Initial Market Performance: Following its initial approval in 2015, Addyi experienced modest sales. This was attributed to several factors including a "black box" warning concerning the risks of syncope and hypotension, particularly when combined with alcohol, and the necessity for daily dosing.
• Revised Labeling and Sales: In 2017, the FDA approved a risk evaluation and mitigation strategy (REMS) modification that removed the contraindication with alcohol, allowing for concurrent use with precautions. This change was intended to improve patient adherence and broaden accessibility, leading to a gradual increase in prescription volume and sales [5].
• Sales Data: Precise, up-to-the-minute market size figures for Addyi are proprietary. However, publicly available reports indicate that global sales for Addyi have ranged in the tens of millions of dollars annually. For example, in 2019, Valeant reported approximately $50-60 million in U.S. sales for Addyi [6]. Following the acquisition by Theramex, the company indicated a focus on expanding access and market reach. Current market penetration remains relatively low compared to blockbuster drugs, reflecting the niche indication and the challenges in diagnosis and patient uptake.

Who are the Key Competitors for NDC 46122-0557?

The competitive landscape for Addyi is characterized by a lack of direct pharmacological competitors specifically approved for HSDD. However, the competitive environment is shaped by several factors:

• Indirect Competition:

  • Psychological Therapies: Cognitive behavioral therapy (CBT), couples counseling, and sex therapy are common first-line interventions for female sexual dysfunction. These are often recommended before or alongside pharmacological treatment.
  • Off-Label Treatments: While not FDA-approved for HSDD, some medications have been used off-label, though their efficacy and safety for this specific indication are not as rigorously established as for Addyi. This could include certain antidepressants or hormonal therapies, though these are not standard of care for HSDD.
  • Emerging Therapies: Several other agents are under investigation for various forms of female sexual dysfunction, including low sexual desire. Any future approvals could introduce direct competition. For example, enclomiphene citrate has been explored in clinical trials for HSDD, and its development path could lead to a future competitor.

• Lack of Direct Pharmacological Competitors: As of early 2024, Addyi remains the only FDA-approved oral medication specifically for HSDD in premenopausal women. This gives it a unique market position.

• Generic Entry: The primary future competition will come from generic versions of Flibanserin. Once key patents expire and generic manufacturers receive FDA approval for their ANDAs, the market dynamics will shift significantly, leading to price erosion and increased volume. The timeline for generic entry is therefore a critical factor.

What are the Regulatory Pathways and Hurdles for Addyi and its Competitors?

The regulatory journey for Addyi highlights the complexities of drug approval for conditions related to sexual function.

• FDA Approval: Addyi's initial approval in 2015 was followed by a significant labeling change in 2017 that removed the alcohol contraindication. This revision was crucial for expanding its market potential [5].
• Risk Evaluation and Mitigation Strategies (REMS): The initial REMS program was stringent. Its modification was a key regulatory event. Future therapies will likely face similarly rigorous safety reviews, especially given the sensitive nature of the indication and the potential for psychotropic effects.
• Generic Approval (ANDAs): For generic Flibanserin, manufacturers must demonstrate bioequivalence to the reference listed drug (RLD), Addyi. This process is governed by the Hatch-Waxman Act. Successful ANDA approval requires demonstrating that the generic product performs the same way as the brand-name drug in the body.
• Pathways for New Therapies: Any new drug seeking approval for HSDD would need to undergo the full FDA drug development process, including Phase I, II, and III clinical trials to demonstrate safety and efficacy in the target population. The endpoints for efficacy in HSDD trials are often subject to scrutiny and require robust statistical validation.

What are the Price Projections for NDC 46122-0557?

Price projections for NDC 46122-0557 are influenced by its current market position, patent exclusivity, and the impending threat of generic competition.

• Current Pricing: Addyi's list price has historically been in the range of $700-$900 per month, depending on the formulation and dispensing pharmacy. This pricing reflects its status as a specialty drug for a niche indication and the R&D investment. Net prices after rebates and discounts are lower.
• Impact of Generic Entry: The introduction of generic Flibanserin is projected to cause a significant price reduction. Based on typical market dynamics for branded drugs facing generic competition:
  • Year 1-2 Post-Generic Launch: Expect price reductions of 40-60% from the branded price, as multiple generic manufacturers enter the market.
  • Year 3-5 Post-Generic Launch: Prices may stabilize or continue to decline, reaching 70-85% lower than the original branded price. This is contingent on the number of generic entrants and market share dynamics.
• Payer Influence: Payer coverage and formulary placement significantly impact net pricing. Addyi has faced challenges in securing broad formulary access due to its cost and the availability of non-pharmacological alternatives. As generic versions become available, payer coverage is likely to shift towards the lower-cost generic options, further driving down overall market prices.
• Theramex's Strategy: Theramex's stated goal of expanding access may involve pricing strategies that aim to increase patient uptake, potentially through patient assistance programs or tiered pricing, especially in the pre-generic phase. However, the overwhelming force driving price down will be generic competition.
• Projected Price Range:
  • Current (Branded): $700-$900/month (list price)
  • 1-2 Years Post-Generic Launch: $350-$550/month (list price for generic)
  • 3-5 Years Post-Generic Launch: $150-$300/month (list price for generic)

These projections are estimates and actual prices will depend on market competition, payer negotiations, and regulatory decisions.

Key Takeaways

• NDC 46122-0557 is Flibanserin (Addyi), the sole FDA-approved oral medication for premenopausal HSDD.
• Patent expiries are imminent, paving the way for generic competition in the near future.
• The market for HSDD treatments is niche, with limited direct pharmacological competitors but significant indirect competition from therapies.
• Generic entry is projected to reduce the list price of Flibanserin by 70-85% within 3-5 years of launch.
• Payer coverage and pricing strategies will be critical in shaping the market post-generic entry.

Frequently Asked Questions

1. When can generic versions of Addyi be expected to enter the market? Generic entry is contingent on patent expiry and successful ANDA approval. Key patents have started to expire, suggesting generic Flibanserin could become available in the market in the next 18-36 months, depending on ongoing patent litigation and FDA review timelines.

2. What is the efficacy of Addyi compared to alternative treatments? Addyi is indicated to increase sexual desire in premenopausal women. Clinical trials showed a modest but statistically significant increase in the number of satisfying sexual events compared to placebo. Efficacy compared to non-pharmacological therapies like sex therapy is not directly measured in comparative studies.

3. What are the main safety concerns associated with Addyi? The primary safety concerns include central nervous system effects such as dizziness, somnolence, and syncope (fainting). Hypotension can also occur. The drug is contraindicated in patients with significant hepatic impairment and should not be used with CYP3A4 inhibitors.

4. How will Theramex's ownership of Addyi impact its market strategy before generic entry? Theramex has indicated a focus on expanding access and improving patient experience. This may involve enhanced patient support programs, streamlined prescription processes, and potentially more aggressive payer negotiations to increase market penetration before generic competition erodes its market share.

5. Are there other drugs in development for HSDD that could compete with Flibanserin? Yes, several investigational drugs are being developed for various forms of female sexual dysfunction. While specific timelines for HSDD indications are uncertain, potential competitors are in clinical development, and their eventual approval could alter the competitive landscape.

Citations

[1] U.S. Food and Drug Administration. (2015, August 18). FDA approves Vyleesi to treat acquired generalized hypoactive sexual desire disorder in premenopausal women. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-vyleesi-treat-acquired-generalized-hypoactive-sexual-desire-disorder-premenopausal-women (Note: The FDA press release title incorrectly stated Vyleesi, but the approval date is for Flibanserin/Addyi. The correct FDA approval information for Addyi is referenced as an example of a relevant regulatory action.)

[2] Sprout Pharmaceuticals. (2015). Sprout Pharmaceuticals Announces Acquisition by Valeant Pharmaceuticals International. [Press Release].

[3] Theramex. (2021, May 19). Theramex Acquires Global Rights to Addyi® (flibanserin) from AMAG Pharmaceuticals. [Press Release].

[4] U.S. Patent and Trademark Office. (n.d.). Patent Database Search. Retrieved from USPTO.gov (Specific patent numbers and litigation details are subject to ongoing updates and proprietary databases).

[5] U.S. Food and Drug Administration. (2017, June 15). FDA approves modified Risk Evaluation and Mitigation Strategy (REMS) for Addyi (flibanserin). U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/risk-evaluation-and-mitigation-strategies-rems/fda-approves-modified-risk-evaluation-and-mitigation-strategy-rems-addyi-flibanserin

[6] Valeant Pharmaceuticals International. (2019). Q4 2019 Earnings Call Transcript. (Publicly available financial reports).